Scientific Safety Lead - ophthalmic products in Fort Worth, TX at Apex Life Sciences

Date Posted: 9/25/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    9/25/2018
  • Job ID:
    889510

Job Description


Responsibilities:

  • Serve as a scientific safety lead for assigned ophthalmic products (intraocular lenses and cataract equipment).
  • Perform single case medical review in the safety database or line listings and prepare safety narratives.
  • Provide guidance for coding, causality assessment, and determination of anticipated vs. unanticipated adverse event reports.
  • Monitor the clinical safety of assigned products/projects, including literature review, adverse events, patient impact from technical complaints.
  • Provide safety input into clinical and regulatory deliverables, including Investigators Brochures, study protocols, reports, and clinical submission documents.
  • Provide medical/scientific guidance to local affiliates on safety issues.
  • Contribute to signal detection, monitoring, evaluation, and appropriate management of safety information from all sources (clinical through post-approval lifecycle management).
  • Contribute to post-market surveillance plans, periodic safety update reports, product labeling, and related documents.
  • Prepare and present safety issues to internal governance boards.
  • Lead cross-functional projects and support the Safety Management Team.
Qualifications:
  • Bachelor's degree in a Scientific field required; Advanced degree preferred
  • Ophthalmologist or Optometrist with extensive knowledge in ophthalmic surgeries may be considered
  • 4+ years of industry experience in product development, clinical trial methodology, and regulatory requirements preferred¬†
  • Prior experience in cataract surgery a plus
  • Proven ability to analyze, interpret, and discuss safety information
  • Excellent written and verbal communication skills

**For immediate consideration, please email your updated resume to ksavas@apexlifesciences.com with 'Scientific Safety Lead' in the subject line.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




889510